A phase 1, open-label, non-randomized, 2-period, fixed sequence study to investigate the absorption, distribution, metabolism and excretion of 14C-PF-06651600 and to assess the absolute bioavailability and fraction absorbed of PF-06651600 in healthy male participants using a 14C-microtracer approach

A phase 1, open-label, non-randomized, 2-period, fixed sequence study to investigate the absorption, distribution, metabolism and excretion of 14C-PF-06651600 and to assess the absolute bioavailability and fraction absorbed of PF-06651600 in healthy male participants using a 14C-microtracer approach - PF-06651600 ADME microtracer study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48152

Enrollment

Registered

2019-03-19

Start date

2019-04-23

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autoimmune and inflammatory diseases

Interventions

In the Period 1 on Day 1 the volunteer will be given PF-06651600 with the radioactive label as a drink of 240 mL. The volunteer will have to fill out a taste assessment questionnaire immediately aft

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male subjects - 18-55 yrs, inclusive - BMI: 18.0-30.0 kg/m2, inclusive - total bodyweight > 50 kg

Exclusion criteria

Exclusion criteria: 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy). 3. Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency. 4. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm. a. For hepatitis B, all participants will undergo testing for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb). Participants who are HBsAg positive are not eligible for this study. Participants who are HBsAg negative but HBcAb positive will be reflex tested for hepatitis B surface antibody (HBsAb). b. For hepatitis C, all participants will undergo testing for hepatitis C antibody (HCVAb) during Screening. • Participants who are HCVAb positive will be reflex tested for hepatitis C RNA (HCV RNA). Participants who are HCVAb and HCV RNA positive are not eligible for the study.

Design outcomes

Primary

Measure	Time frame
Mass Balance: Cumulative recovery (%) of radioactivity in urine and feces.	—

Secondary

Measure	Time frame
- Metabolic profiling/metabolite identification in plasma, urine and fecal sample. - PK parameters of PF-06651600 from plasma concentration: Cmax, AUClast, AUCinf, Tmax, t* (half-life), CL (IV) & CL/F (Oral), Vss(IV) & Vz/F (Oral). - PF-06651600 AUCinf from both oral PF-06651600 and IV 14C-PF-06651600 (Period B only) plasma data. - Total 14C urine data following both IV (Period B) and oral (Period A) administration of 14C-PF-06651600 (quantification by AMS). - Adverse event (AE) monitoring, physical examination, clinical laboratory measurements, vital signs.	—

Measure

Time frame

- Metabolic profiling/metabolite identification in plasma, urine and fecal sample. - PK parameters of PF-06651600 from plasma concentration: Cmax, AUClast, AUCinf, Tmax, t* (half-life), CL (IV) & CL/F (Oral), Vss(IV) & Vz/F (Oral). - PF-06651600 AUCinf from both oral PF-06651600 and IV 14C-PF-06651600 (Period B only) plasma data. - Total 14C urine data following both IV (Period B) and oral (Period A) administration of 14C-PF-06651600 (quantification by AMS). - Adverse event (AE) monitoring, physical examination, clinical laboratory measurements, vital signs.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)